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Psychedelic Therapy
Psilocybin for Depression in Autism (PAT-DA Trial)
Phase 1
Waitlist Available
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Autistic adult, ages 18-65
Intellectually able: Either the participant has a previous report showing intelligence quotient (IQ) ≥ 70 on the General Abilities Index of the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) or any other standardized intelligence scales, or the participant scores >10 percentile on the nine-item form of the Raven's Standard Progressive Matrices Test (RSPM)
Must not have
The presence of any clinically significant or unstable medical conditions, including cardiovascular, liver, kidney, pulmonary disease, presence of known congenital brain malformation, as per investigator assessment based on medical history and chart review
Timeline
Screening 3 weeks
Treatment Varies
Follow Up administered at follow-up visits post-intervention (visits 5-9)
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the safety and effectiveness of using psilocybin, a compound found in certain mushrooms, to treat depression in autistic adults who have not responded to other treatments. Participants will receive therapy
Who is the study for?
This trial is for adults with autism who also have depression that hasn't improved with standard treatments. Participants should be able to communicate effectively and handle the demands of the study, which includes around 20 hours of specialized psychotherapy.
What is being tested?
The trial is testing psilocybin, a compound found in certain mushrooms, as a treatment for depression in autistic adults. It involves two doses: a smaller safety dose followed by a larger treatment dose, alongside psychotherapy designed to work with psilocybin.
What are the potential side effects?
Psilocybin can cause headaches, nausea, increased heart rate and blood pressure, psychological distress or anxiety during use. Long-term side effects are not well understood but could include changes in mood or sensory perception.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult between 18 and 65 years old with autism.
Select...
I have an IQ score of 70 or above, or scored in the top 10% on the Raven's test.
Select...
I have been diagnosed with major depression without psychosis.
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My depression hasn't improved after trying two or more antidepressants.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any serious or unstable health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ administered at follow-up visits post-intervention (visits 5-9)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~administered at follow-up visits post-intervention (visits 5-9)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of Administering Psilocybin in Conjunction with Psychotherapy in Autistic Adults
Feasibility of Dense Sampling Brain MRI Procedures & Trial Design
Number of Participants with Treatment-Related Adverse Events as Assessed by SBQ-ASC & UKU Side Effect Rating Scale
Secondary study objectives
Changes & Variance in Brain Functional Connectivity Assessed Across Dense Sampling Brain MRI Sessions
Changes in Brain Network Interactions as Assessed with Pre- and Post-Intervention MRI Brain Scans
Subjective Psychedelic Effects as Measured by the 11-Dimensions of Altered States of Consciousness (11D-ASC) Rating Scale
Other study objectives
Antidepressant Efficacy of Psilocybin-Assisted Psychotherapy for Autistic Adults with Treatment-Resistant Depression
Changes in Psychological Symptoms & Features Theoretically Associated with Psilocybin-Assisted Psychotherapy & Depression
Side effects data
From 2021 Phase 2 trial • 95 Patients • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open-labelExperimental Treatment1 Intervention
Safety Dosing Session (V3): 10mg of psilocybin + therapy + safety evaluations
Active Treatment Session (V4): 25mg of psilocybin + therapy + safety evaluations
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~530
Find a Location
Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
375 Previous Clinical Trials
82,867 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
320 Patients Enrolled for Autism Spectrum Disorder